Cancer remains one of the leading global causes of death, with the National Cancer Institute estimating approximately 20 million new cases and 9.7 million cancer-related deaths worldwide in 2022. Projected figures suggest these numbers might rise sharply to roughly 29.9 million new cases annually by 2040.
Addressing this grave issue, Japanese biotech startup Craif, spun out of Nagoya University in 2018, is pioneering an advanced, non-invasive cancer detection platform built on microRNA (miRNA) analysis. The company has secured $22 million in Series C funding to accelerate its expansion in the U.S. market and advance its research and development capabilities. The funding round, led by existing investor X&KSK, brings Craif’s total raised capital to $57 million. Notably, the round also attracted investments from the U.S.-based impact investors Unreasonable Group, marking their first investment in a Japanese startup, as well as support from TAUNS Laboratories, Daiwa House Industry, and Aozora Bank Group.
In an interview, Craif co-founder and CEO Ryuichi Onose confirmed the latest investment places the startup’s valuation just shy of $100 million. He noted the deeply personal motivation behind Craif’s origin, recounting how cancer had significantly impacted his family, including both grandparents being diagnosed. Together with co-founder Takao Yasui, an associate professor at Nagoya University who developed an innovative early cancer detection technique leveraging urine biomarkers, Onose established Craif shortly after they first met.
Traditional methods of early cancer screening like blood tests are often considered invasive, costly, or inconvenient, discouraging regular check-ups among many individuals, Onose explained. Additionally, limitations in access to medical facilities exacerbate these obstacles. Craif seeks to fill this gap by offering a highly user-friendly urine-based test capable of early detection, even at very preliminary stages such as stage 1. This test, branded miSignal, uses sophisticated AI-powered microRNA analysis to provide accurate early alerts of cancer risk, allowing users to conduct the tests conveniently from their own homes.
“Urine is an ideal sampling medium because it’s easy, non-invasive, and possesses fewer impurities than blood, leading to clearer and more consistent biomarker signals,” Onose explained. This reduces measurement errors associated with traditional methods, such as hemolysis in blood samples, helping to lower testing costs.
Craif distinguishes itself significantly from industry competitors—such as Grail, Freenome, DELFI Diagnostics, and Clearnote Health—by focusing on microRNA instead of cell-free DNA (cfDNA). The field of miRNA garnered increased attention after its engagement with cancer biology was recognized in the awarding of the Nobel Prize in Medicine in 2024. Onose highlighted miRNA’s particular advantage over CfDNA, pointing out that miRNA is actively secreted by cancer cells from early-stage tumors, making it a more precise indicator of incipient malignancies.
miSignal already detects risk for seven cancers: pancreatic, colorectal, lung, stomach, esophageal, breast, and ovarian cancers. It has gained substantial traction in Japan, generating approximately $5 million in revenue in 2024, with targets to triple that figure to $15 million by the end of this year. Craif currently collaborates with over 1,000 medical institutions and about 600 pharmacies across Japan, serving around 20,000 users through clinics, pharmacies, direct-to-consumer channels, and corporate wellness initiatives.
The company’s business model includes single-purchase tests as well as subscription-based offerings, with a significant portion of customers opting for ongoing subscriptions. In the near term, Craif plans to broaden miSignal’s predictive capabilities from seven cancers to more than ten in the next year. Additionally, the startup is exploring the application of its technology to the early detection of non-cancerous chronic illnesses, including neurodegenerative diseases like dementia.
Onose noted that the newly secured capital will also facilitate Craif’s U.S. entry. The company anticipates completing clinical trials by the close of 2026 and securing approval from the U.S. Food and Drug Administration as early as 2027. To support these efforts, Craif has already begun collecting pancreatic cancer samples via partnerships with 30 medical institutions across 15 U.S. states. The company operates an established R&D laboratory in Irvine, California, and has plans underway to launch a business development office in San Diego.
